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FDA 510(k)

IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR

K-Number: K082364 · 2008-09-30

ApplicantTopcon Corp.
Decision Date2008-09-30
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corp.. It received FDA 510(k) clearance on 2008-09-30 under 510(k) number K082364. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR?

IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR is a medical device that received FDA 510(k) clearance on 2008-09-30. The listed applicant is Topcon Corp.. The 510(k) number is K082364.

When did IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR receive FDA 510(k) clearance?

IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR received FDA 510(k) clearance on 2008-09-30, under 510(k) number K082364.

Who is the listed applicant for IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR?

The FDA 510(k) record lists Topcon Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR?

The FDA product code for IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR is NFJ.

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Other records listing Topcon Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130289TRC-NW8 NON-MYDRIATIC RETINAL CAMERAK100207NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8FK092470OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000K090115RETINA CAMERA TRC-NW7SF MARK IIK063388TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEMK041367TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA

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Related Devices (Code: NFJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260694ZEISS CLINIC 360Carl Zeiss Meditec, AGK253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA OyK234076iCare ALTIUS CWCentervue S.P.A.K232828IMAGEnet6 Ophthalmic Data SystemTopcon CorporationK232944CALLISTO eyeCarl Zeiss Meditec, AGK232555HarmonyTopcon Healthcare Solutions

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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